CLINICAL EFFICACY AND SAFETY OF CEFETAMET PIVOXIL IN TODDLERS

The safety and efficacy of cefetamet pivoxil, an oral cephalosporin of the third generation, have been studied in open, prospective, randomi zed comparative, clinical trials including 301 toddlers (children aged 1 to 2 years) with upper and lower respiratory tract infections, and urinary tract infections. Cefetamet pivoxil (CAT) syrup formulation wa s given to 177 toddlers either in the standard dose of 10 mg/kg b.i.d. [n = 116] or 20 mg/kg b.i.d. [n = 61] and 124 toddlers have been trea ted with comparator drugs [cefaclor, n = 98; phenoxymethylpenicillin, n = 18; amoxicillin plus clavulanic acid; n = 8]. The treatment period was 7 days mainly, except for pharyngotonsillitis for which the treat ment duration was 7 or 10 days. The assessment of treatment was based on clinical signs and symptoms primarily in infections of lower respir atory tract and acute otitis media, whereas in patients with pharyngot onsillitis and acute urinary tract infections the bacteriological find ings were the main evaluation criteria. The overall therapeutic outcom e was successful in 148 (95.4%) of the 155 toddlers to whom CAT was ad ministered and in 87 (85.3%) out of 102 toddlers receiving standard dr ugs. Adverse events of mild to moderate severity, mainly of gastro-int estinal type (vomiting or diarrhoea) occurred in 14.7% in the patient group receiving CAT, 11.2% in the toddlers receiving the standard dose of CAT, and in 12.9% with the comparator drugs. From the data present ed it is concluded that cefetamet pivoxil is efficient and safe in tod dlers presenting with community-acquired respiratory and urinary tract infections mainly caused by S. pneumoniae, H. influenzae, Group A bet a-haemolytic streptococci, M. catarrhalis, E. coli, Proteus spp. and K pneumoniae.